The present invention relates to an apparatus and method for making the appearance of cellulite less obvious by cutting the fibrous bridges that connect the skin to muscle and/or fascia (hereinafter referred to as “muscle,” “fascia,” or “muscle/fascia”) or by cutting the fibrous septae in subcutaneous fat in a minimally invasive manner, and specifically to a percutaneous cellulite removal needle with at least one lateral opening in its peripheral surface through which a surgical instrument and/or a cutting mechanism retracts or protrudes and methods for using the percutaneous cellulite removal needle.
Cellulite is a popular term used to describe the dimpled or “lumpy skin” appearance of the skin that some people have on their hips, thighs, and buttocks. Cellulite often occurs in women who are not particularly overweight or a good candidate for liposuction. It is caused by a “buttoning” or “mattress effect” of the skin 24 with tethering of the dermis 22 to the underlying muscle or fascial layers 26 by fibrous bands 28 or by fibrous septae in the subcutaneous fat.
Dietary supplements, topical creams, massage treatments, and other methods have been suggested for treatment of cellulite. There are few scientific studies, however, that demonstrate the efficacy of any of these methods. Nor is liposuction—a surgical technique for extracting fat by vacuuming it from under the skin—always an effective treatment for cellulite. This is because the dimpled appearance is the result of deposits of subcutaneous fat in combination with the fibrous bridges that attach the skin to underlying muscle. When the fibrous bridges tighten, the skin is pulled tight over the deposits of subcutaneous fat creating a dimpled appearance. Removal of the subcutaneous fat by liposuction does not alter the dimpled appearance of the skin and, in fact, may worsen the appearance of the skin. In order to smooth the skin, it is necessary to break the fibrous bridges.
A method for the treatment of cellulite by breaking fibrous bridges is disclosed in Surgical Treatment of Cellulite and its Results, by Clara Lieberman, M.D. and Joseph Cohen, M.D., American Journal of Cosmetic Surgery, Vol. 16, No. 4, 1999, 299-303. The Lieberman-Cohen method is a surgical treatment using liposuction and release of the fibrous tissue bridges with blunt thin cannulas. Specifically, the cannulas break the fibrous bridges that originate from the herniation of subcutaneous fat. While this method represents a significant advance in the treatment of cellulite, a disadvantage of this method is that it uses an instrument that was not designed for the purpose of cutting fibrous bridges or septae. The use of a liposuction cannula is invasive, awkward, imprecise, and physically difficult.
Because treatment of cellulite by breaking fibrous bridges or septae is a recent development, prior art surgical devices were not developed with this purpose in mind. Prior art cutting devices generally contemplate cutting tissue other than fibrous bridges using a cutting mechanism located at the distal tip of the device. Several representative prior art devices are described below. Each of the devices described would need to be used in the same manner that the liposuction cannula is employed in the Lieberman-Cohen method and suffers from the same and additional disadvantages.
U.S. Pat. No. 3,526,219 to Balamuth (the “Balamuth reference”) is directed to a method and apparatus for ultrasonically microchopping tissue and removing the tissue fragments from a body. The Balamuth device has a fine edge that is vibrated in the ultrasonic frequency range and accelerated above 50,000 g to produce a tissue breakdown fundamentally different from tissue slicing. A fluid stream controls temperature while a built-in suction machine removes tissue and fluid. Because the Balamuth fine edge is located at the distal tip, the device is adapted only for removal of tissue directly ahead of the distal tip.
U.S. Pat. No. 5,690,664 to Sauer et al. is directed to a laparoscopic trocar that has a cutting blade positioned inside the distal tip of the trocar for penetrating the peritoneum. The Sauer trocar is pistol-shaped and an operator deploys the distally located cutting blade by pulling a trigger. Movement of the cutting blade between the non-deployed and deployed positions facilitates tissue penetration by cutting the tissue directly ahead of the distal tip of the trocar.
An example of a surgical cutting instrument for removing sections of bodily tissue taking a slightly different approach from the devices discussed above is U.S. Pat. No. 6,152,894 to Kubler (the “Kubler reference”). The Kubler instrument is a pointed linear shank percutaneously insertable through a trocar. Once inserted, an external actuator pulls a cord inside the device that deforms the distal end of the shank into a curved sickle shape. Cutting blades are arranged along the inside curve of the curved sickle and a spherical piece of tissue located at the end of the shank may be excised by rotating the shaft of the Kubler device. Although the Kubler approach is somewhat different, the tissue cut is still directly ahead of the distal tip of the device.
U.S. Pat. No. 5,419,761 to Narayanan et al. (the “Narayanan reference”) is directed to a cannula for an ultrasonic liposuction method. The Narayanan cannula transmits an ultrasonic wave through the cannula producing cavitation at the distal tip. Adipose tissue is liquefied in front of the distal tip and aspirated through a bore in the cannula. A disadvantage of the Narayanan cannula is that the intensity of the ultrasonic wave would likely need to be increased substantially to sever fibrous tissue and this increase would likely result in unwanted ancillary damage to nearby tissue. In addition, the tissue acted upon is still directly ahead of the distal tip of the device.
U.S. Pat. No. 5,569,291 to Privitera et al. (the “Privitera reference”) is directed to a surgical penetration instrument for dissection having a tube through which an endoscope can be inserted. The endoscope locks into place so that movement relative to the tube is prevented. A conical transparent tip on the tube allows the endoscope to visualize the insertion path and treatment site. The conical tip has two blades positioned 180 degrees apart that extend longitudinally from the tip to the base of the conical tip. The blades are for facilitating insertion and cutting target tissues. The Privitera device views and cuts tissue only directly ahead of the distal tip.
U.S. Pat. No. 5,797,944 to Nobles et al. (the “Nobles reference”) is directed to a laparoscopic trocar allowing a view. The Nobles trocar has blades positioned on a pointed head for percutaneous insertion. A slanted window on the pointed head and a hollow shaft allow visualization by an optional endoscope. The Nobles reference provides a view only directly ahead of the distal tip of the device.